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YY/T 0920-2014: Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
YY/T 0920-2014
YY
INDUSTRY STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
YY/T 0920-2014 / ISO 21535:2007
Non-active surgical implants - Joint replacement implants -
Specific requirements for hip-joint replacement implants
(ISO 21535:2007, IDT)
ISSUED ON: JUNE 17, 2014
IMPLEMENTED ON: JULY 1, 2015
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 Expected performance ... 8
5 Design attributes ... 8
6 Materials ... 9
7 Design evaluation ... 10
8 Manufacturing ... 11
9 Sterilization ... 11
10 Packaging ... 11
11 Information provided by the manufacturer ... 11
Appendix A (Informative) Evaluation of relative angular motion of components ... 14
References ... 16
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is translated and identical to ISO 21535:2007 Non-active surgical
implants - Joint replacement implants - Specific requirements for hip-joint replacement
implants.
The Chinese documents that have consistent correspondence with the international
documents normatively cited in this standard are as follows:
-- YY/T 0640-2008 Non-active surgical implants - General requirements (ISO
14630:2005, IDT)
-- YY/T 0809.1 Implants for surgery - Partial and total hip joint prostheses - Part 1:
Classification and designation of dimensions (YY/T 0809.1-2010, ISO 7206-
1:2008, IDT)
-- YY/T 0809.2 Implants for surgery - Partial and total hip joint prostheses - Part 2:
Articulating surfaces made of metallic, ceramic and plastic materials (YY/T
0809.2-2010, ISO 7206-2:1996, MOD)
-- YY/T 0809.4 Implants for surgery - Partial and total hip joint prostheses - Part 4:
Determination of endurance properties of stemmed femoral components (YY/T
0809.4-2010, ISO 7206-4:2002, MOD)
-- YY/T 0809.6 Implants for surgery - Partial and total hip joint prostheses - Part 6:
Determination of endurance properties of head and neck region of stemmed
femoral components (YY/T 0809.6-2010, ISO 7206-6:1992, MOD)
-- YY/T 0809.10 Implants for surgery - Partial and total hip joint prostheses - Part
10: Determination of resistance to static load of modular femoral heads (YY/T
0809.1-2010, ISO 7206-10:2003, MOD)
Please note that some of the contents of this document may involve patents. The issuing
agency of this document is not responsible for identifying patents.
This standard was proposed by China Food and Drug Administration.
This standard shall be under the jurisdiction of the Sub-Technical Committee on
Orthopedics Implants of the National Technical Committee on Implants for Surgery and
Orthopedic Devices of Standardization Administration of China (SAC/TC110/SC1).
Drafting organizations of this standard: Committee for Surgical Implants Chinese
Association of Medical Device Industry, Tianjin Medical Devices Quality Supervision
Non-active surgical implants - Joint replacement implants -
Specific requirements for hip-joint replacement implants
1 Scope
This standard specifies specific requirements for hip joint replacement implants.
With regard to safety, this standard specifies requirements for expected performance,
design attributes, materials, design evaluation, fabrication, sterilization, packaging, and
information provided by the manufacturer, as well as test methods.
2 Normative references
The following documents are essential to the application of this document. For the dated
referenced documents, only the versions with the indicated dates are applicable to this
document; for the undated referenced documents, only the latest version (including all
the amendments) is applicable to this document.
YY/T 0640-2008 Non-active surgical implants - General requirements (ISO
14630:2005, IDT)
YY/T 0809.1 Implants for surgery - Partial and total hip joint prostheses - Part 1:
Classification and designation of dimensions (YY/T 0809.1-2010, ISO 7206-
1:2008, IDT)
YY/T 0809.2-2010 Implants for surgery - Partial and total hip joint prostheses -
Part 2: Articulating surfaces made of metallic, ceramic and plastic materials (ISO
7206-2:1996, MOD)
YY/T 0809.4 Implants for surgery - Partial and total hip joint prostheses - Part 4:
Determination of endurance properties of stemmed femoral components (YY/T
0809.4-2010, ISO 7206-4:2002, MOD)
YY/T 0809.6-2010 Implants for surgery - Partial and total hip joint prostheses -
Part 6: Determination of endurance properties of head and neck region of stemmed
femoral components (ISO 7206-6:1992, MOD)
YY/T 0809.10 Implants for surgery - Partial and total hip joint prostheses - Part 10:
Determination of resistance to static load of modular femoral heads (YY/T
0809.10-2010, ISO 7206-10:2003, MOD)
11.3 Structural and functional compatibility of components
11.3.1 If a femoral component or modular femoral head is only expected to be
compatible with the structures and functions of specific acetabular cups, the compatible
acetabular cups shall be stated in its label, instruction leaflet, or manual.
11.3.2 If an acetabular component is only expected to be compatible with the structures
and functions of specific femoral components, the compatible femoral components
shall be stated in its label, instruction leaflet, or manual.
11.3.3 For a femoral component and head of modular construction, the label, instruction
leaflet, or manual shall state for each, the corresponding components with which they
are structurally and functionally compatible.
NOTE: In general, components made by different companies may not match. This applies in particular
to modular components with male or female tapered connections.
11.4 Marking
11.4.1 The nominal diameter of the femoral head shall be marked on a monobloc
femoral component.
11.4.2 A modular femoral head shall be marked to identify its nominal outer diameter
and the characteristics of the cone and bore connection. In normal or corrected vision,
these markings shall be legible.
11.4.3 For the stemmed femoral component of the hip joint replacement implant
matched with the modular femoral head in the way of a male/female tapered connection,
as long as the expected function of the component is not damaged, there shall be a mark
indicating the connection method. Markings required for identification or other reasons
may be located on the neck of the femoral component of a hip joint replacement implant
only if it is proven that endurance property will not be impaired. For stemmed femoral
components fitted with modular femoral heads, the marking shall be located on the
proximal end face of the conical region where the femoral head is fitted. In normal or
corrected vision, the marking shall be clear.
11.4.4 The acetabular component with the articular surface of a total hip joint
arthroplasty shall be marked with the nominal diameter of the articular surface. In
normal or corrected vision, the marking shall be clear.
11.5 Information provided to patients
The manufacturer shall at least make the following statement or equivalent statement
in the instruction leaflet or manual:
“Patients receiving hip joint replacements should be advised that the longevity of the